Intrapartum Non-invasive Electrophysiological Monitoring

NCT06135961 | Recruiting

• 1 other identifier: NL82822.015.22
• Study Type: interventional
• Target: 3,471
• Locations: 1 country
• Sites: 1

Brief Summary

Conventional cardiotocography (CTG) has been used extensively for more than 50 years to monitor the fetal condition during labour, but since the rate of operative deliveries keeps rising, its ability to improve neonatal outcomes is unsatisfactory. A transabdominal non-invasive and wireless alternative which overcomes the shortcomings of conventional methods is electrophysiological CTG (eCTG) monitoring. In eCTG the fetal heart rate (FHR) is measured by fetal electrocardiography (NI-fECG) and uterine activity (UA) by electrohysterography (EHG). Both NI-fECG and EHG have been proven more accurate and reliable than conventional non-invasive methods and are less affected by maternal body mass index (BMI). This study aims to evaluate the mode of delivery, maternal and perinatal outcomes, costs and patient and healthcare professionals perspectives on eCTG monitoring versus the conventional CTG during labour at term with a singleton fetus in cephalic position. The eCTG provides a more accurate assessment of the fetus and the UA, compared to the conventional CTG. This allows for optimization of the contraction pattern during high-risk deliveries. We hypothesize that this will reduce the number of operative interventions and improves perinatal outcome. There are three reasons why an improvement in the contraction pattern by the eCTG can influence our outcomes:

1. 1.EHG can detect excessive UA more accurately. Increased UA is a major risk for fetal distress. In this case, stimulation with oxytocin should be reduced or stopped. More adequate interpretation of FHR, reduced tachysystole and reduced hypertonia is expected to result in fewer instrumented vaginal deliveries and a reduction of caesarean sections due to fetal distress.
2. 2.EHG can demonstrate unorganized UA that needs to be corrected with a higher dose of oxytocin to enhance contraction frequency and efficiency. This can result in a less exhausted uterine muscle, shorter time to delivery, less vacuum deliveries and caesarean sections due to failure of progress. A shorter time to delivery will also result in a reduction of infections and blood loss.
3. 3.Accurate registration of the relation between the contraction and decelerations of FHR, is expected to result in more reliable assessment of the fetal condition. This can result in fewer unnecessary operative deliveries and less unpredictable poor perinatal outcomes.

Conditions

Fetal Monitoring; Non-invasive; Cardiotocography; Electrocardiography; Caesarean Section

Outcome Measures

Primary Outcomes (1)

• The number of operative interventions during labor

  cesarean section or instrumental vaginal delivery

  During delivery

Secondary Outcomes (35)

• Duration of the first stage of labor in minutes

  0-10 cm dilation during labor

• Duration of the second stage of labor in minutes

  Start pushing until childbirth

• The timing and reason of operative interventions during labor

  During delivery

• The number of participants with analgesia for pain reduction: epidural or/and remifentanil

  During delivery

• Perineal laceration (grade 1, 2, 3a, 3b, 3c, 4)

  Directly after childbirth

Study Arms (2)

eCTG monitoring

ACTIVE COMPARATOR

eCTG monitoring with the Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands). The NFMS consists of a wireless and beltless electrode patch on the maternal abdomen. It monitors fetal heart rate by fetal electrocardiography, maternal heart rate by maternal electrocardiography and the electrical activity of the uterine muscle by electrohysterography. The advantage of the NFMS is that it is a safe method that can be used in all situations that are contraindicated for invasive monitoring. Furthermore, it can be used when the membranes are not ruptured and the patch does not have to be repetitively repositioned during labor. Because the NFMS is wireless, it gives women more freedom of movement during labor.

Device: eCTG monitoring with the NFMS

Conventional CTG monitoring

NO INTERVENTION

Philips Avalon FM 30 (Philips Healthcare, Eindhoven, the Netherlands). The fetal heart rate is measured non-invasively by doppler ultrasound or invasively by fetal scalp electrode. The uterine activity and maternal heart rate is measured by tocodynamometry.

Interventions

eCTG monitoring with the NFMS DEVICE

Device: Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands)

eCTG monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimal age of 18 years old
• Pregnant women with a gestational age between 37+0 and 42+0 weeks and days
• Indication for fetal monitoring during labour
• Singleton fetus in cephalic position
• Oral and written informed consent is obtained

You may not qualify if:

• Insufficient knowledge of Dutch or English language
• Women with a multiple pregnancy
• Fetal and/or maternal cardiac arrhythmias
• Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)
• Women connected to an external or implanted electrical stimulator, such as Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance of the electrophysiological signal)
• Women who take a bath for multiple times during delivery and/or who take a bath for \> 1 hour during the first stage of labour and/or who take a bath in the second stage of labour. eCTG monitoring is impossible in bath because the Bluetooth signal is disturbed. In bath, monitoring will be performed by conventional CTG monitoring. However, it is possible to take a shower with eCTG monitoring
• Women who were included in the study, but when circumstances before labour call for delivery of the baby by unplanned caesarean section.
• There is insufficient time for proper counselling
• Women admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).

Sponsors & Collaborators

• Maxima Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Maxima MC

Veldhoven, North Brabant, 5504 DB, Netherlands

RECRUITING

Related Publications (1)

• Berben PBQ, de Klerk ND, van der Ven M, Fransen AF, Niemarkt HJ, van den Heuvel ER, van der Hout-van der Jagt MB, Oei SG, van Laar JOEH. Non-invasive electrophysiological monitoring vs conventional monitoring during labour in a tertiary obstetric care centre in the Netherlands: study protocol of a cohort intervention random sampling study (NIEM-II study). BMJ Open. 2025 Jul 22;15(7):e102901. doi: 10.1136/bmjopen-2025-102901.

  PMID: 40701589 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, PhD Candidate, Coordinating Investigator NIEM-II study

Model Details: Eligible women will be prospectively included in the cohort receiving conventional CTG monitoring. From the eligible women in the prospective cohort a random sample (90.9%) will be offered eCTG monitoring via a computer generated random collection. Participants will receive eCTG monitoring from the start of fetal monitoring during labour until 1.5 hour after delivery. A retrospective cohort of 2100 women who received conventional CTG monitoring between April 2019 and February 2023 will be added to the prospective cohort for statistical analysis.

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 18, 2023
• Study Start: November 20, 2023
• Primary Completion: November 20, 2025
• Study Completion: February 15, 2026
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)